Global pharmaceutical leader Lupin Limited (Lupin) (BSE: 500257) (NSE: LUPIN) (REUTERS: LUPIN.BO) (BLOOMBERG: LPCIN) announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Modafinil Tablets USP, 100 mg and 200 mg.

The U.S. FDA has approved Lupin's Modafinil Tablets USP, 100 mg and 200 mg as bioequivalent to the reference listed drug (RLD), Provigil® Tablets of Nuvo Pharmaceuticals (Ireland) DAC, and is indicated to improve  wakefulness in adult patients with excessive sleepiness associated with  narcolepsy, obstructive sleep apnea (OSA) or shift work disorder (SWD).

Modafinil Tablets (RLD Provigil®) had estimated annual sales of USD 70.7 million in the U.S. (IQVIA MAT Jul 2026).